-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MdAHH5AtXFdnMdc4q/9zpuQlHlJrW83bmB4NqeID25krw5QZ7unhaGeB9FrtRtMI h/zRe0bgLK9GYkBNi65Aow== 0000897101-01-500817.txt : 20020413 0000897101-01-500817.hdr.sgml : 20020413 ACCESSION NUMBER: 0000897101-01-500817 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20011212 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: FILED AS OF DATE: 20011213 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDAMICUS INC CENTRAL INDEX KEY: 0000833140 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 411533300 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19467 FILM NUMBER: 1812859 BUSINESS ADDRESS: STREET 1: 15301 HGHWY 55 W CITY: PLYMOUTH STATE: MN ZIP: 55447 BUSINESS PHONE: 7635592613 8-K 1 medamicus015175_8k.txt MEDAMICUS, INC. FORM 8K SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (date of earliest event reported): December 12, 2001 MedAmicus, Inc. --------------- (Exact name of Registrant as specified in its charter) Minnesota 0-19467 41-1533300 - ---------------------------- ------------ ------------------- (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 15301 Highway 55 West Plymouth, Minnesota 55447 - ---------------------------- ------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (763) 559-2613 Items 1, 2, 3, 4, 5, 6, and 8 are not applicable and therefore omitted. ITEM 9. REGULATION FD DISCLOSURE - --------------------------------- On December 12, 2001, the President and Chief Executive Officer of MedAmicus, Inc. (the "Company"), James D. Hartman, began use of the slide presentation attached hereto as Exhibit 99.1 which summarizes information about the Company, its products, industry and prospects. The information contained in the slides was presented to securities fund managers and securities analysts in individual meetings. ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS - ------------------------------------------ 99.1 Slide Presentation SIGNATURE Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. MEDAMICUS, INC. By: /s/ James D. Hartman ------------------------------------- President and Chief Executive Officer Dated: December 13, 2001 EX-99.1 3 medamicus015175_ex99-1.txt MEDAMICUS SLIDES EXHIBIT 99.1 [LOGO] MEDAMICUS INCORPORATED MEDAMICUS, INC. [LOGO] MEDAMICUS INCORPORATED FORWARD-LOOKING STATEMENTS This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Certain important factors could cause results to differ materially from those anticipated by some statements made herein. All forward-looking statements involve risks and uncertainties. Among the factors that could cause results to differ materially are the following: the Company's dependence upon a limited number of key customers for its revenue; the Company's dependence upon licensing agreements with third parties for the technology underlying some of its products, especially the safety needle; successful implementation of the Company's safety needle production ramp-up schedule; attracting and retaining key personnel; lack of market acceptance of the Company's products, especially the safety needle; introduction of competitive products; patent and government regulatory matters; economic conditions; and the ability to raise capital. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the Company are expressly qualified by these cautionary statements. In addition, the Company disclaims any obligation to update forward-looking statements to reflect events or circumstances after December 13, 2001. [LOGO] MEDAMICUS INCORPORATED LEADING THE WAY TO SAFER, SIMPLER MEDICAL PROCEDURES [LOGO] MEDAMICUS INCORPORATED BALANCE SHEETS - -------------------------------------------------------------------------------- (in 000's) 9/30/01 12/31/00 % chg -------- -------- ----- Cash $ 3,592 $ 1,007 +256% Receivable from Cooper 289 - Receivables, inventory & ppds 3,822 3,150 + 20% Deferred tax asset 678 - Property, plant and equipment 2,253 1,335 License agmt & other assets 2,102 69 -------- -------- Total assets $ 12,736 $ 5,561 +129% -------- -------- Payable to bank $ - $ 1,551 Payable to Med-Design 1,000 - Other current liabilities 1,550 1,163 Long-term liabilities 246 215 Stockholder's equity 9,940 2,632 +278% -------- -------- Total liabilities and shareholder's equity $ 12,736 $ 5,561 +129% -------- -------- [LOGO] MEDAMICUS INCORPORATED INVESTOR ISSUES * 315,000 warrants to be exercised before 1/20/02 -if exercised, will increase shares o/s to 4.7 million -will bring in cash $1.7 million * Shares underlying warrants plus 68,000 shares of stock issued to Med-Design are now registered (S-3 available) * 22% of outstanding shares now owned by institutions * Insider ownership is less than 5% [LOGO] MEDAMICUS INCORPORATED LEADING THE WAY TO SAFER, SIMPLER MEDICAL PROCEDURES OUR BUSINESS OPPORTUNITIES [LOGO] MEDAMICUS INCORPORATED GROWTH OPPORTUNITIES * EXPAND CORE VENOUS INTRODUCER CUSTOMER BASE - Market share grows from less than 20% to near 40% - Bard Access contract makes Company market leader * ADVANCED DELIVERY PRODUCTS AID NEW PROCEDURES - MedAmicus plays key role in Medtronic's CHF therapies - Medtronic FDA approval provides near-term boost to sales * SAFETY NEEDLES - Med-Design ARTERIAL and venous license places MedAmicus as leader in guidewire introducer safety needles - Automation will provide capacity to expand on opportunities [LOGO] MEDAMICUS INCORPORATED VENOUS INTRODUCER USAGE [BAR CHART] 2,400 2,550 2,750 2,925 ------------------------------------- 2000 2001 2002 2003 * Signed large volume supply agreements in 2000 * Annual introducer volume increasing to 1 million * 40% market share - the largest supplier in the world * Market share increase likely from future designs [LOGO] MEDAMICUS INCORPORATED WHY MEDAMICUS IS MARKET LEADER IN VENOUS INTRODUCERS * Concentration on major companies including Medtronic and Bard Access Systems * Bard Access, largest venous introducer user in world, signed contract with Company in 2000 * Best product and feature offering in industry * Shortest industry lead times * 99% plus on-time delivery over past 4 years * Highly focused OEM supplier [LOGO] MEDAMICUS INCORPORATED CONGESTIVE HEART FAILURE OPPORTUNITY * Medtronic clinical studies indicate left ventricle pacing effective CHF therapy -FDA panel approval in 7/01 -final approval received in 8/01 * Guide catheter needed to reach left ventricle - tortuous path * 750K to 1.25MM Americans are potential candidates * MedAmicus' Slitter technology makes removal of guide catheter possible * MedAmicus Q3 and Q4 results influenced by inventory build at Medtronic; 2002 sales will adjust to normal sell through * Kit sells for premium price today; higher volume will allow for price reductions to Medtronic [LOGO] MEDAMICUS INCORPORATED SAFETY NEEDLES * Law requiring safer sharps devices in effect - Needlestick Safety and Prevention Act * Signed license agreement with Med-Design - Exclusive rights in arterial and venous fields gives Company 13,000,000 procedure opportunity * Centerline retraction technology - Technology applied to a guidewire introducer needle - Easy to use: no user technique change required [LOGO] MEDAMICUS INCORPORATED GUIDEWIRE INTRODUCER SAFETY NEEDLE * FDA 510(k) marketing clearance received July 10, 2001 * Licensed distribution rights - Exclusive in venous, arterial and related fields of use including gastro-enterology and drainage catheters - Also signed cooperation agreement to manufacture needles for spinal and epidural anesthesiology, a/v fistula and blood donor markets * Distribution strategy - All of our introducer customers will need safety needle - Distributor network, GPO's [LOGO] MEDAMICUS INCORPORATED SAFETY NEEDLE DISTRIBUTION * Venous customer contacts made and evaluations in process -the Company expects to start receiving initial commitments before year-end * Arterial opportunities identified and 50% of contacts made * Ten distributor relationships established covering entire US * Director level sales and marketing position to be filled before year-end [LOGO] MEDAMICUS INCORPORATED SAFETY NEEDLE MANUFACTURING * Expect 10,000 per week output by 1/31/02 * $1.5 million investment in automation committed by year-end -on-line September 2002 -increases capacity to 10 million units annually * Automation provides high level of cost competitiveness [LOGO] MEDAMICUS INCORPORATED NEXT GENERATION SAFETY PRODUCT * All-In-One safety introducer - Filed for a patent on device in 11/00 - Separate license agreement with Med-Design - Utilizes centerline retraction technology * For both venous and arterial markets - Designed to replace all the components in an introducer kit - Development underway- targeted early 2003 release [LOGO] MEDAMICUS INCORPORATED SAFETY PRODUCTS MARKET POTENTIAL ---------------------------------------------------- GUIDEWIRE INTRODUCER SAFETY "ALL-IN-ONE" NEEDLE SAFETY INTRODUCER ---------------------------------------------------- Price $3-4 $10 - -------------------------------------------------------------------------------- Annual Venous Procedures 3 Mil. 3 Mil. - -------------------------------------------------------------------------------- Annual Arterial Procedures 7 - 10 Mil. 7 - 10 Mil. - -------------------------------------------------------------------------------- Total Procedures 10 - 13 Mil. 10 - 13 Mil. ================================================================================ MARKET POTENTIAL $30 - 53 MIL. $100 - $130 MIL. - -------------------------------------------------------------------------------- [LOGO] MEDAMICUS INCORPORATED 2002 INFLUENCERS * Sales drivers - Full year of new venous introducer customers - Transition of left ventricular pacing procedure kits to more normal sell through - Safety needle OEM relationships and distribution channels established * Safety needle automation * Development and approvals for Safety Introducer * Search for new opportunities to diversify product line and customer base [LOGO] MEDAMICUS INCORPORATED MEDAMICUS, INC. -----END PRIVACY-ENHANCED MESSAGE-----